See BOXED WARNINGS, WARNINGS, and PRECAUTIONS.

Systemic absorption occurs with the use of Premarin Vaginal Cream. Warnings, precautions, and adverse reactions associated with oral Premarin treatment should be taken into account.

The following adverse reactions have been reported with estrogen and/or progestin therapy:

1. Genitourinary system: Abnormal uterine bleeding/spotting; dysmenorrhea/pelvic pain; increase in size of uterine leiomyomata; vaginitis, including vaginal candidiasis; change in cervical secretion; change in amount of cervical ectropion; cystitis-like syndrome; application site reactions of vulvovaginal discomfort including burning and irritation; genital pruritus; ovarian cancer; endometrial hyperplasia; endometrial cancer.
2. Breasts: Tenderness, pain, enlargement, discharge, galactorrhea; breast cancer; fibrocystic breast changes.
3. Cardiovascular: Deep and superficial venous thrombosis, pulmonary embolism, thrombophlebitis, myocardial infarction, stroke; increase in blood pressure.
4. Gastrointestinal: Nausea, vomiting, abdominal cramps, bloating; cholestatic jaundice; pancreatitis; increased incidence of gallbladder disease; enlargement of hepatic hemangiomas; ischemic colitis.
5. Skin: Chloasma or melasma that may persist when drug is discontinued; erythema multiforme; erythema nodosum; hemorrhagic eruption; loss of scalp hair; hirsutism; pruritis; rash.
6. Eyes: Retinal vascular thrombosis; intolerance to contact lenses.
7. Central Nervous System: Headache; migraine; dizziness; nervousness; mood disturbances; irritability; mental depression; exacerbation of chorea; exacerbation of epilepsy; dementia; possible growth potentiation of benign meningioma.
8. Miscellaneous: Increase or decrease in weight; glucose intolerance; aggravation of porphyria; edema; changes in libido; urticaria, angioedema, anaphylactoid/anaphylactic reactions; hypocalcemia (preexisting condition); exacerbation of asthma; increased triglycerides; arthralgias; leg cramps.

Drug/Laboratory Test Interactions

1. Accelerated prothrombin time, partial thromboplastin time, and platelet aggregation time; increased platelet count; increased factors II, VII antigen, VIII antigen, VIII coagulant activity, IX, X, XII, VII-X complex, II-VII-X complex, and beta-thromboglobulin; decreased levels of antifactor Xa and antithrombin III, decreased antithrombin III activity; increased levels of fibrinogen and fibrinogen activity; increased plasminogen antigen and activity.
2. Increased thyroid-binding globulin (TBG) leading to increased circulating total thyroid hormone, as measured by protein-bound iodine (PBI), T4 levels (by column or by radioimmunoassay) or T3 levels by radioimmunoassay. T3 resin uptake is decreased, reflecting the elevated TBG. Free T4 and free T3 concentrations are unaltered. Patients on thyroid replacement therapy may require higher doses of thyroid hormone.
3. Other binding proteins may be elevated in serum, i.e., corticosteroid binding globulin (CBG), sex hormone-binding globulin (SHBG), leading to increased total circulating corticosteroids and sex steroids, respectively. Free hormone concentrations may be decreased. Other plasma proteins may be increased (angiotensinogen/renin substrate, alpha-1-antitrypsin, ceruloplasmin).
4. Increased plasma HDL and HDL2 cholesterol subfraction concentrations, reduced LDL cholesterol concentration, increased triglyceride levels.
5. Impaired glucose tolerance.

Bookmark this page: